Regulatory: Page 238

FDA issues gadolinium health advisory
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued a health advisory regarding MRI contrast agents containing gadolinium after two dozen cases of a rare disease that developed in European patients following administration of a gadolinium-based agent.
June 14, 2006
FDA awards 510(k) to Barco's CardiaMetrix
By AuntMinnie.com staff writers
Image display and advanced visualization software developer Barco of Kortrijk, Belgium, has received 510(k) clearance from the U.S. Food and Drug Administration for its CardiaMetrix software.
June 13, 2006
Elekta nets Japanese approval
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta has received approval from the Japanese Ministry for Health, Labor, and Welfare for its Synergy image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) systems.
June 13, 2006
Given gets FDA OK for real-time device
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging of Yoqneam, Israel, has received U.S. Food and Drug Administration marketing clearance for its Rapid Access RT product.
June 12, 2006
Medtronic nets French reimbursement approval
By AuntMinnie.com staff writers
Interventional technology firm Medtronic said it has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system.
June 11, 2006
FDA clears GE nuclear cardiology software
By AuntMinnie.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has received U.S. Food and Drug Administration clearance for a new software package for the fusion of PET/CT and SPECT/CT cardiac studies.
June 11, 2006
Medrad gets 3-tesla clearance
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad said that it has received U.S. Food and Drug Administration clearance for use of its Continuum MR infusion system in MR environments up to and including 3 tesla.
June 7, 2006
Fuji mammo CR gets FDA nod
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device.
May 30, 2006
Health IT bill moves forward in U.S. Congress
By AuntMinnie.com staff writers
Legislation that would promote the use of healthcare information technology passed out of a key subcommittee yesterday in the U.S. House of Representatives.
May 24, 2006
UltraSPECT gets U.S. patent
By AuntMinnie.com staff writers
Israeli nuclear medicine developer UltraSPECT has received a U.S. patent, 7,026,623, for its "efficient single-photon emission imaging," according to the Haifa-based vendor.
May 24, 2006
Varian gets FDA nod for Trilogy applications
By AuntMinnie.com staff writers
Radiation oncology vendor Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for new applications for its Trilogy family of linear accelerators, as well as a new Trilogy Tx image-guided radiosurgery model.
May 22, 2006
Boston Scientific gets EC nod for added Liberte uses
By AuntMinnie.com staff writers
Interventional device firm Boston Scientific reported that it has received indication extensions to the European CE Mark for its Taxus Liberte paclitaxel-eluting coronary stent system.
May 15, 2006
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